AMRI Hit With Another 483 in Burlington MA

AMRI Hit With Another 483 in Burlington MA

August 5th, 2013 // 11:50 am @

Latest FDA and cGMP Compliance News

FDA gave another 483 earlier this spring to AMRI, a contract manufacturing organization (CMO) in Burlington MA. The company has gotten two 483s from FDA in recent years. The new 483 had three new observations after a seven day site visit.

Albany Molecular Research noted in a press release that it had gotten the 483, which it claimed was limited in scope and nature, but did not provide additional details.

The plant in Burlington has caused problems for AMRI since the company acquired Hyaluron in 2010. The problems started when FDA sent a warning letter to the firm, citing several serious cGMP violations at the plant.

Another inspection in 2011 resulted in a 7-item 483, which AMRI has been trying to correct in the last 24 months. AMRI claimed that these efforts were effective, saying that no observations were given by FDA in their review of the 483 from 2011. The company stated last week that it is putting together a response to the new 483 that it is going to send to the agency soon.

No details of the 483 have been released at this time, so we can’t say how big of an impact that it is going to have on AMRI’s efforts to get its plant into cGMP compliance.

The plant is continuing to operate without any restrictions at this time.

To learn how to better prevent and respond to 483s and warning letters, please check out our upcoming Webinar Aug. 21, The Hitchhiker’s Guide to 483s and Warning Letters – FDA Compliance Trends, Response and Prevention. 


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